Non Segmental Vitiligo
Conditions
Brief summary
This a phase II/III randomized, double-blind, placebo-controlled, parallel group, adaptive design, multi-center study to evaluate the efficacy and safety of ICP-332 in subjects with non-segmental vitiligo。The study consisted an phase 2 part and an phase 3 part.
Interventions
DRUGICP-332 Tablets
ICP-332 will be administered as tablet
ICP-332 Placebo will be administered as tablet
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged ≥18 years and ≤75 years (Phase II portion). Male or female subjects ≥12 years of age and ≤75 years of age, adolescent subjects must weigh ≥40 kg (Phase III portion). 2. Eligible subjects must meet all of the following criteria at screening and baseline: 1. The clinical diagnosis was non-segmental vitiligo for at least 3 months. 2. Involvement of BSA≥5%. 3. Facial involvement BSA≥0.5%. 4. F-VASI≥0.5 and T-VASI between 5 and 50. 5. Active or stable non-segmental vitiligo was present at both screening and baseline visits. 3. Women of childbearing potential (WOCBP) and Men must agree to contraception. 4. Before beginning any screening or study specific procedures, subjects must voluntarily sign informed consent.
Exclusion criteria
1. Any of the following vitiligo related medical conditions and other skin diseases/conditions. a) Subjects had other types of vitiligo (including but not limited to segmental vitiligo and mixed vitiligo) that did not meet the criteria for active or stable vitiligo described in Inclusion criteria 2. 2. History of any clinically major diseases, with the exception of vitiligo. 3. Pregnant or breastfeeding females. 4. The investigator considers that the subject is not suitable for participation in this study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase2: Percent change from baseline in facial vitiligo area scoring index (F-VASI) at week 24. | 24 weeks |
| Phase3: Proportion of subjects achieving F-VASI 75 at Week 52. | 52 weeks |
Countries
China
Contacts
Primary ContactFlora Xiang, Doctor
Outcome results
None listed